FDA EIR - Valerie K Arnold MD - March 09, 2007

An FDA Clinical Investigator/Data Audit inspection was conducted at the practice of Dr. Valerie K. Arnold, M.D., in Memphis, TN, between February 19 and March 9, 2007. This comprehensive review, mandated by CDER's Division of Scientific Investigations under Good Clinical Practice (GCP) principles, focused on Dr. Arnold's role as Principal Investigator for studies related to a high-priority drug pre-approval application. The inspection involved an extensive audit comparing case report forms and raw data with sponsor submissions, reviewing informed consents, and examining IRB and sponsor correspondence for specific drug studies.

While the inspection identified protocol deviations, such as study visits and assessments completed outside designated timeframes, or missed dosages, all such instances were thoroughly explained and documented within the study records. This indicates that despite the deviations, the site maintained proper accountability. The report also provided historical context, noting a previous 2004 inspection that resulted in an FDA-483 citing issues like source file changes not transferred to case report forms and omissions in interview booklet data. However, for the current 2007 inspection, the findings did not warrant further discussion or the issuance of a new Form FDA 483. Consequently, no new regulatory actions were required from Dr. Arnold or her staff based on this specific Establishment Inspection Report, demonstrating satisfactory resolution of observed deviations.